Status:
NOT_YET_RECRUITING
GUIDEX® Versus Launcher™ Guiding Catheter in Percutaneous Coronary Intervention (PCI) (GUIDEX_FR)
Lead Sponsor:
Tianjin Demax Medical Technology Co., Ltd
Collaborating Sponsors:
CEISO
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to compare two guiding catheters in patients with coronary artery disease during a percutaneous coronary intervention between Guidex® Guiding catheter (DEMAX) and La...
Detailed Description
Cardiovascular disease (CVD) remains the most common cause of death in the European region. In line with the Global Burden of Disease (GBD) estimates from 2001, 43% of all Cardio Vascular Disease (CVD...
Eligibility Criteria
Inclusion
- Patients need to be at least 18 years old.
- Patients with significant coronary artery disease who qualify for PCI (according to ACC/AHA/SCAI 2021 guidelines, including that the patient has received medical therapy with exercise and dietary recommendations before or at the same time as the PCI decision and that the clinical decision depends on the cardiology team) and who can be treated with a radial and femoral approach
- Patients scheduled for for Percutaneous Coronary Intervention and must remain overnight for observation
- The target vessel must have a TIMI flow 3 at baseline
- Palpable radial or fermoral artery
- Patients covered by the social security system
Exclusion
- Concomitant use of Atherectomy, specialty balloon (intravascular lithotripsy), or investigational coronary devices (intravascular ultrasound, or optical coherence tomography)
- Active bleeding or significant increased risk of bleeding, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy.
- Prior PCI procedure within the last 30 days of the index procedure
- Current platelet count \<100 x 10\^9cells/L or Hgb \<10 g/dL.
- Uncontrolled severe hypertension (systolic BP \>180 mm Hg or diastolic BP \>110 mm Hg)
- Target vessel \< 2.4 mm in diameter
- Target lesion \> 32 mm in length
- Patient has allergy to imaging contrast media for which they cannot be pre-medicated
- Patients with hypersensitivity or contraindication to antiplatelet treatment
- Patient unable to stop his or her daily oral medication includes metformin treatment during 48 hours.
- Unstable patient: myocardial infarction, cardiogenic shock or with troponin above the upper limit of the normal laboratory value in the 24 hours prior to the procedure OR with elevated troponin and abnormal concomitant CK (non-exhaustive list).
- Unable to follow the requirements of the protocol.
- Vulnerable: whose ability or freedom to give or refuse consent is limited.
- Patients who cannot read or write french;
- Major protected by law (tutorship, curatorship, safeguarding justice...).
- Patient is pregnant or nursing
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06009757
Start Date
August 1 2024
End Date
February 1 2025
Last Update
July 3 2024
Active Locations (1)
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1
CHU Toulouse
Toulouse, France, 31300